Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49633–49656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2010
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
K102129 · DWA
Levitronix, LLC
Cardiovascular · 29d
Cleared Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
K102157 · JJY
Roche Diagnostics
Chemistry · 28d
Cleared Aug 26, 2010
STAR/VENT INTERNAL HEX SCREW IMPLANT
K082800 · DZE
Park Dental Research Corp.
Dental · 701d
Cleared Aug 26, 2010
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE...
K093420 · NTI
Luminex Molecular Diagnostics, Inc.
Chemistry · 296d
Cleared Aug 26, 2010
MDPO FRAME SYSTEM
K093753 · KTT
Mdpo, LLC
Orthopedic · 262d
Cleared Aug 26, 2010
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
K100210 · MAX
Trans1 Incorporated
Orthopedic · 213d
Cleared Aug 26, 2010
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
K100684 · GKH
Veridex, LLC
Hematology · 169d
Cleared Aug 26, 2010
INBONE II TOTAL ANKLE REPLACEMENT
K100886 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 149d
Cleared Aug 26, 2010
SHIMADZU COLLIMATOR R-20J
K101036 · IZX
Shimadzu Corp.
Radiology · 134d
Cleared Aug 26, 2010
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503,...
K101100 · MAI
Conmed Linvatec
Orthopedic · 128d
Cleared Aug 26, 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · KLE
Bisco, Inc.
Dental · 90d
Cleared Aug 26, 2010
JOURNEY CR KNEE SYSTEM
K101499 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Aug 26, 2010
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION...
K101645 · LYY
Latexx Manufacturing Sdn.Bhd.
General Hospital · 76d
Cleared Aug 26, 2010
TENZING SYSTEM
K102130 · HAW
Mazor Surgical Technologies , Ltd.
Radiology · 28d
Cleared Aug 25, 2010
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE...
K093175 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 321d
Cleared Aug 25, 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
K093604 · JWY
Ab Biomerieux
Microbiology · 278d
Cleared Aug 25, 2010
DUFLO CATHETER (HEPARIN COATED)
K093847 · MJN
Thermopeutix, Inc.
Cardiovascular · 252d
Cleared Aug 25, 2010
SURGIMAX/ SURGIMAX PLUS
K100390 · GEI
Elliquence, LLC
General & Plastic Surgery · 190d
Cleared Aug 25, 2010
TACAMO MANUAL WHEELCHAIR
K101719 · IOR
Dalton Instrument Corp.
Physical Medicine · 68d
Cleared Aug 25, 2010
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
K101728 · BSP
Cook, Inc.
Anesthesiology · 65d
Cleared Aug 25, 2010
RAPIDVUE HCG TEST
K102175 · JHI
Quidel Corporation
Chemistry · 23d
Cleared Aug 24, 2010
LARYNGEAL SURFACE ELECTRODE
K093373 · ETN
Spes Medica Srl
Ear, Nose, Throat · 299d
Cleared Aug 24, 2010
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · NHX
Bio-Rad Laboratories
Immunology · 244d
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · HBB
Medtronic Sofamor Danek
Neurology · 120d